Director Biostatistics HEOR & Medical Affairs

We have a current opportunity for a Director Biostatistics HEOR & Medical Affairs on a permanent basis. The position will be based in Boston, MA or remote. For further information about this position please apply.

The Director of Biostatistics HEOR (Health Economics and Outcomes Research) will lead the biostatistics team in designing, analyzing, and supporting health economics and outcomes research studies and Medical Affairs for oncology products. This role involves strategic planning, methodological development, and collaboration with cross-functional teams to support evidence generation and decision-making processes. This incumbent will ensure the scientific integrity and quality of biostatistical analyses and contribute to the development of HEOR strategies that demonstrate the value of healthcare interventions.

Base Salary: $210-250,000 + additional benefits

Key Responsibilities

• Leadership and Management:

  • Lead and mentor a team of biostatisticians, providing guidance and fostering professional development.
  • Oversee the planning, execution, and reporting of biostatistical analyses for HEOR studies.
  • Ensure adherence to regulatory requirements and industry standards in all biostatistical activities.
  • Provide statistical leadership for HTA, post-marketing studies, retrospective analyses, registry studies, and patient-reported outcomes.

• Strategic Planning:

  • Develop and implement biostatistical strategies to support HEOR objectives.
  • Collaborate with HEOR, clinical, and market access teams to align biostatistical methodologies with overall research goals.
  • Identify and address methodological challenges in HEOR studies.

• Study Design and Analysis:

  • Design robust and innovative statistical approaches for health economics and outcomes research.
  • Perform and oversee statistical analyses, including survival analysis, regression modeling, and cost-effectiveness analysis.
  • Interpret and communicate statistical findings to internal and external stakeholders.

• Collaboration and Communication:

  • Work closely with cross-functional teams, including clinical development, medical affairs, and market access, to integrate biostatistical insights into broader research initiatives.
  • Present biostatistical results at scientific conferences, regulatory meetings, and to key opinion leaders.
  • Prepare and review manuscripts, reports, and presentations for publication and dissemination.

• Quality Assurance and Compliance:

  • Ensure the accuracy, reliability, and validity of biostatistical analyses.
  • Maintain compliance with regulatory guidelines and best practices in biostatistics.
  • Implement quality control procedures and continuous improvement initiatives.

Qualifications

• Education:

  • PhD or Master's degree in Biostatistics, Statistics, Epidemiology, or a related field.

• Experience:

  • Minimum of 10 years of experience in biostatistics, expert oncology expertise, with a focus on HEOR Settings/ leadership within medical affairs
  • Proven track record of leading biostatistical teams and managing complex projects.
  • Experience in the pharmaceutical, biotechnology, or healthcare industry preferred.

• Skills:

  • Expertise in statistical software (e.g., SAS, R, STATA).
  • Strong analytical and problem-solving skills.
  • Excellent communication and presentation skills.
  • Ability to work collaboratively in a multidisciplinary environment.